Felogen Xl 10mg Prolonged Release Tablets
PACKAGE LEAFLET: INFORMATION FORTHE USER
FELOGEN XL 10 mg PROLONGED-RELEASE TABLETS
(Felodipine)
Read all of this leaflet carefully before you start
taking using this medicine.
• Keep this leaflet. You may need to read it again.
• If you haveany furtherquestions.askyour doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Felogen XL is and what it is used for.
2. Before you take Felogen XL.
3. Flow to take Felogen XL.
4. Possible side effects.
5. Flow to store Felogen XL.
6. Further information.
1. WHAT FELOGEN XL IS AND WHAT IT IS USED FOR
Felogen XL is in the form of a 'prolonged release' film-coated tablet. This means that the tablet has an effect for a long time after taking it, so that it only needs to be taken once a day. It contains felodipine which belongs to a group of medicines called calcium channel blockers. They allow the blood vessels in the body and heart to relax and widen, allowing more blood to flow to the heart and around the body. Felogen XL is used to treat high blood pressure (hypertension).
2. BEFORE YOU TAKE FELOGEN XL
Do not take Felogen XL if:
• you are allergic (hypersensitive) to felodipine or any of the ingredients in Felogen XL
(see Section 6: Further information)
• you are allergic to dihydropyridine medicines (such as nifedipine oramlodipine)
• you have something called unstable angina (angina that is not well controlled by medical treatment)
• you have severe heart problems
• you have had a heart attack in the last month
• you have something called cardiogenic shock
(a serious condition where the heart is unable to supply enough blood to the body)
• you are pregnant or trying to get pregnant (see Pregnancy and breastfeeding below).
Do not take Felogen XL if any of the above apply to you. Ifyouare not sure, talkto yourdoctoror pharmacist.
Take special care with Felogen XL
Before you take Felogen XL, tell your doctor if:
• you have liver problems
• you have heart problems (i.e. faster heart beats, high and/or low blood pressure).
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines.This includes herbal medicines and medicines that you buy without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Cimetidine (for ulcers)
• Erythromycin (for bacterial infections)
• Itraconazole or ketoconazole (for fungal infections)
• HIV protease inhibitors (such as ritonavir)
• Phenytoin, carbamazepine or phenobarbital (for epilepsy)
• Tracrolimus (used after kidney or liver transplant)
• Rifampicin (used for treatment of tuberculosis)
• St John's Wort (Hypericum perforatum) (used to treat depression and anxiety)
• Barbiturates (a sedative)
• Efavirenz or Nevirapine (used to treat HIV)
• Warfarin (used to thin the blood)
• Ciclosporin (mainly used by transplant patients but also used to treat rheumatoid arthritis and psoriasis).
Taking Felogen XL with food and drink
Do not drinkgrapefruitjuice when you are taking this medicine.This can increase the effect of Felogen XL. Do not take this medicine with fatty foods. This can alter the effect of Felogen XL.
Pregnancy and breast-feeding
Do not take Felogen XL if you are pregnant or trying to get pregnant. This is because Felogen XL can harm your unborn baby.
If you are breast-feeding, talk to your doctor before taking Felogen XL.
Driving and using machines
Do not drive or operate machinery if you feel less alert while taking this medicine. This is more likely at the start of treatment, if your doctor increases your dose oryou have been drinking alcohol.
Important information about some of the ingredients of Felogen XL
This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you are intolerant to some sugars, talkto your doctor before taking this medicine.
3. HOW TO TAKE FELOGEN XL
Always take Felogen XL as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole with a full glass of water. The tablets may be taken on an empty stomach or with a light meal not high in fat or carbohydrates (sugar).
Do not divide, chew or crush the tablets, lti 392AB
The usual dose is:
Adults
The usual starting dose is 5 mg once a day in the morning. After 2 weeks or more, your doctor may increase the dose to 10 mg once a day.
If necessary, your doctor may also prescribe you other antihypertensive medicines to reduce your blood pressure further (such as a beta-blocker or diuretic).The maximum daily dose is 10 mg a day.
Elderly (over 65 years)
Your doctor will give you the lowest possible dose and monitor you closely.
Patients with liver problems
If you suffer from liver problems your doctor may give you a lower dose of Felogen XL.
Children (under 18 years)
There is limited experience with the use of Felogen XL in children (below the age of 18 years). Therefore Felogen XL should not be given to children.
If you take more Felogen XL than you should
Contact your doctor or nearest hospital emergency department immediately.Takethecontainerand any remaining tablets with you. Symptoms of overdose include low blood pressure and slow heart beat.
If you forget to take Felogen XL
Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Felogen XL
Do not stop taking your medicine as it may cause serious changes in your blood pressure.
If you have any further questions on the use of this medicine.askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Felogen XL can cause side effects, although not everyone gets them.
If any of the following happen to you, stop taking Felogen XL and tell your doctor straight away:
• Chest pain and dizziness at the same time.
• An allergic reaction. The signs may include raised lumps on your skin (weals) or swelling on your face, lips, mouth, tongue and throat.
Other possible side effects:
Very common (affect more than 1 in 10 people):
• swelling ofthefeetand ankles.
Common (affects less than 1 in 10 people)
• headaches
• flushing of your skin
Uncommon (affects less than 1 in 100 people)
• faster heartbeat
• pounding heartbeat (palpitations)
• pinsand needles feeling inyourtoesand fingers
• stomach pain
• feeling sick (nausea)
• rash
• itching
• dizziness
• feeling tired.
Rare (affects less than 1 in 1,000 people)
• fainting
• being sick
• pain in joints
• pain in muscles
• being unable to get an erection (impotence)
• lumpy rash (hives).
Very rare (affects less than 1 in 10,000 people)
• enlarged gums (if you already have enlarged gums they may get worse. You can prevent this by careful dental hygiene)
• increased levels of liver enzymes
• skin inflammation
• sensitivity of sunlight
• passing water (urine) more often, normally during the daytime
• allergic reaction (anaphylaxis i.e. swelling ofyour face, lips, mouth, tongue or throat, fever).
You may get any of the following side effects at the beginning of treatment or if your dose has been increased:
• flushing, headaches, faster or pounding heartbeat, feeling dizzy or tired.
Do not be alarmed by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOWTO STORE FELOGEN XL
Keep out of the reach and sight of children. Do not store your tablets above 25°C. Do not use Felogen XL after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Felogen XL contains
The active substance is felodipine. Each tablet contains 5 mg or 10 mg felodipine.The other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, povidone, propyl gallate, colloidal anhydrous silica, magnesium stearate, iron oxide red (El 72), iron oxide yellow (El 72), titanium dioxide (El 71), talc, propylene glycol.
What Felogen XL looks like and the contents of the pack
The 5 mg tablets are light pink, round, marked '5'. The 10 mg tablets are reddish-brown, round, marked '10'. Felogen XL is available in blister packs of 10,14, 20,28,30,50, 56,60,98 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics UJK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Date of revision: November 201 2 LT1392AB 10003619